Recall Z-1419-06 ยท ILY Lamp, Infrared, Therapeutic Heating
Biocare Systems Inc.
LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, BioCare Systems, Inc.
| Date | Aug 24, 2006 (initiated Jun 14, 2006) |
| Status | Terminated |
| Reason | Electrical Safety Hazard-when pulling on the cord of the AC adapter, to remove it from an outlet, the prongs on the AC adapter, may detach from the unit, damaging it and exposing the user to an electrical safety hazard |
| Root cause | Other |
| Action | Consignees were notified by telephone beginning 06/08/2006, followed by a letter on 06/23/2006. |
| Quantity | 175 units |
| Distribution | Nationwide distribution --- including the states of CA, CO, IL, MA, MD, MI, NC, FL, PA, TX, UT, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051816 | LUMIWAVE 1X4 INFRARED THERAPY DEVICE Biocare Systems, Inc., Aug 26, 2005 |